跳至主要内容
临床试验/NCT01162616
NCT01162616已完成早期 1 期

Is There a Dose-dependant Effect of Sorghum Polyphenols on Human Iron Absorption and Can it be Overcome by Sodium Iron EDTA or by Adding Vitamin C or Laccase?

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Iron isotope ratio in blood samples

研究概览

简要总结

Iron deficiency and iron deficiency anemia are two major public health problems in developing countries. In these countries, the use of monotonous plant-based diets, low in animal source food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor iron status or aggravate poor iron status caused by infections. In many West African countries sorghum is a major source of energy, protein, vitamins and minerals especially for the most poverty-stricken people. Some sorghum varieties are known to contain high levels of polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a huge group of plant metabolites with varying chemical structures. Depending on their structure, the level of complex formation with iron in the intestine and thus the negative effect on iron absorption is different.

Micronutrient deficiency can be combated by fortification of plant-based staples. Fortification is a promising food-based approach which can be applied when other strategies fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods with iron, a wide variety of different iron compounds have been used. The iron compound sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in presence of polyphenol is available.

The aims of the study are to investigate the effect of different sorghum polyphenol concentrations on human iron absorption and to investigate if the negative impact of the polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32 apparently healthy young women which will consume sorghum porridges with different polyphenol levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA. Furthermore test meals with added vitamin C or added laccase will be compared to a control meal. Iron absorption will be determined by stable isotope technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females of reproductive age, 18-40 years
  • Maximum body weight 65 kg
  • Normal body mass index (18.5-25 kg/m2)
  • No intake of mineral/vitamin supplements 2 weeks before and during the study
  • No metabolic or gastrointestinal disorders

排除标准

  • Pregnancy or lactation
  • Regular intake of medication (except oral contraceptives)
  • Blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
  • Former participation in a study involving administration of iron stable isotopes
  • Subject who cannot be expected to comply with study protocol
  • Eating disorders or food allergy
  • High C-reactive protein levels (>5 mg/L)

结局指标

主要结局

Iron isotope ratio in blood samples

时间窗: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)

Whole blood samples will be collected to measure the shift in iron isotope ratios 16 days after administration of isotopic label in the first test meal. First test meal on study day 1, Second test meal on study day 2, Third (last) test meal on study day 3, Measurement of iron isotopic shift in blood samples collected on study day 17

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Michael B. Zimmermann

Msc

Swiss Federal Institute of Technology

研究点 (2)

Loading locations...

相似试验